Buccolam

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Buccolam Medicine

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Incompatibilities

Not applicable

List of excipients

Sodium chloride

Water for injections

Hydrochloric acid (for pH adjustment and conversion of midazolam to the hydrochloride salt)

Sodium hydroxide (for pH adjustment)

Preclinical safety data

In a rat fertility study, animals dosed up to ten times the clinical dose, no adverse effects on fertility were observed.

There are no other preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.

Date of revision of the text

05/2016

Marketing authorisation holder

Shire Services BVBA

rue Montoyer 47

1000 Brussels

Belgium

Special precautions for storage

Keep the oral syringe in the protective plastic tube.

Do not refrigerate or freeze.

Nature and contents of container

Amber, pre-filled needle-free oral syringe (polypropylene) with plunger (polypropylene) and end cap (high density polyethylene) packed in a protective, capped plastic tube.

Strength

Volume of solution

Syringe volume

Age range

Label colour

2.5 mg

0.5 ml

1 ml

3 months to < 1 year

Yellow

5 mg

1 ml

3 ml

1 year to < 5 years

Blue

7.5 mg

1.5 ml

3 ml

5 years to < 10 years

Purple

10 mg

2 ml

3 ml

10 years to < 18 years

Orange

BUCCOLAM is available in cartons containing 4 pre-filled syringes.

Marketing authorisation number(s)

BUCCOLAM 2.5 mg oromucosal solution

EU/1/11/709/001

BUCCOLAM 5 mg oromucosal solution

EU/1/11/709/002

BUCCOLAM 7.5 mg oromucosal solution

EU/1/11/709/003

BUCCOLAM 10 mg oromucosal solution

EU/1/11/709/004

Special precautions for disposal and other handling

Administration of BUCCOLAM

BUCCOLAM is not for intravenous use.

Step 1

Hold the plastic tube, break the seal at one end and pull the cap off. Take the syringe out of the tube.

Step 2

Pull the red cap off the tip of the syringe and dispose of it safely.

Step 3

Using the finger and thumb gently pinch and pull back the child's cheek. Put the tip of the syringe into the back of the space between the inside of the cheek and the lower gum.

Step 4

Slowly press the syringe plunger until the plunger stops.

The full amount of solution should be inserted slowly into the space between the gum and the cheek (buccal cavity).

If necessary (for larger volumes and/or smaller patients), approximately half the dose should be given slowly into one side of the mouth, then the other half given slowly into the other side.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Date of first authorisation/renewal of the authorisation

Date of first authorisation: 05 September 2011

Date of latest renewal: 26 May 2016